Benefit-Risk Expert - Global Epidemiology & Benefit-Risk Evaluation - Global Pharmacovigilance at Sanofi
Marie-Laure Kürzinger has more than 20 years of experience in Epidemiology. Before joining the pharma industry, Marie-Laure worked in academia where she developed field epidemiology expertise.
In 2008, she joined the pharma industry first at Sanofi Pasteur MSD in the vaccine area and then at Sanofi as an Associate Director of Pharmacoepidemiology. Since 2018, she is a benefit-risk expert and leads the development of benefit risk models for drugs under development but also marketed drugs in close collaboration with stakeholders from other functions (e.g. pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical operations, affiliates).
Title: Structured and Quantitative Benefit-Risk evaluation for medicinal products: how can it make a difference?
- Among regulators, HTAs, industry and academia, BR evaluation has shifted into a more structured and quantitative approach and the role of patient preference in the medicinal product decision-making has increased
- Various frameworks and methods for structured Benefit-Risk evaluation have been developed
- Real world examples of structured quantitative benefit-risk evaluations which contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval will be provided